Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am being treated with DBL Rocuronium Bromide?
DBL Rocuronium Bromide contains the active ingredient rocuronium bromide. Rocuronium
is a muscle relaxant that is used when you/your child have an operation. It may also
be used to relax the muscles in your windpipe making it easier to insert a tube to
help you breathe during surgery or in the intensive care unit (ICU).
2. What should I know before treatment with DBL Rocuronium Bromide?
Do not use if you/your child have ever had an allergic reaction to rocuronium or any
of the ingredients listed at the end of the CMI.
Talk to your doctor if you/your child have any other medical conditions, take any
other medicines, are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with DBL Rocuronium Bromide and affect how it works.
Examples include medicines used to: make you sleep during surgery; numb your body
during a medical procedure; treat severe allergies and inflammation; treat infections;
treat depression or bipolar disorder; treat heart disease or high blood pressure,
treat fluid retention; treat malaria; treat pregnant women experiencing high blood
pressure or toxins in the urine; treat epilepsy.
4. How will DBL Rocuronium Bromide be given to me?
DBL Rocuronium Bromide will be given to you by a doctor, by injection into a vein.
5. What should I know while using DBL Rocuronium Bromide?
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Things you should do
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Before you/your child’s operation, discuss your/your child’s medical history with
your doctor.
Tell your doctor if you/your child are taking any other medicines, including any medicines,
vitamins or supplements that you buy without a prescription from your pharmacy, supermarket
or health food shop.
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Driving or using machines
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Your doctor will tell you when it is safe to drive and operate potentially dangerous
machinery after you have been given DBL Rocuronium Bromide
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Drinking alcohol
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No information available.
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Looking after your medicine
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DBL Rocuronium Bromide is stored in the hospital.
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6. Are there any side effects?
Side effects include sudden life-threatening allergic reactions (shortness of breath,
wheezing, coughing or difficulty breathing, swelling of the face, lips, or tongue
which may cause difficulty swallowing, swelling in other parts of the body; feeling
lightheaded or dizzy, skin rash, itching, hives;) rapid, shallow breathing, cold,
clammy skin, a rapid, weak pulse, feeling weak and fainting; sudden fever, rapid or
irregular heartbeat, chest pain, rapid breathing, stiffness, pain and/or weakness
in your muscles; loss of movement; dilated/enlarged pupils or fixed pupils; pain or
irritation at the injection site; flushing.
Active ingredient(s):
Rocuronium (Rok-you-RO-nee-um)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL™ Rocuronium Bromide. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using DBL Rocuronium Bromide.
Where to find information in this leaflet:
1. Why am I being given DBL Rocuronium Bromide?
DBL Rocuronium Bromide contains the active ingredient
rocuronium bromide.
Rocuronium is a muscle relaxant that is used when you/your child have an operation.
It may also be used to relax the muscles in your windpipe making it easier to insert
a tube to help you breathe during surgery or in the intensive care unit (ICU).
DBL™ Rocuronium Bromide is not addictive.
2. What should I know before treatment with DBL Rocuronium Bromide?
Warnings
DBL Rocuronium Bromide should not be used if you are allergic to rocuronium bromide,
or any of the ingredients listed at the end of this leaflet.
Check with your doctor if you/your child:
have kidney, liver or gall bladder disease
have heart disease
have swollen hands, ankles or feet
have disease affecting the nerves and muscles (e.g., polio, myasthenia gravis, Eaton-Lambert
Syndrome
have ever developed complications during anaesthesia, e.g., uncontrolled shivering
due to a drop in body temperature or sudden fever with rapid heartbeat, rapid breathing
and stiffness, pain and/or weakness in your muscles
general ill-health (e.g., sudden, unexplained weight loss, fatigue, weakness)
blood tests have shown any of the following medical conditions:
low potassium, calcium or protein levels in the blood
high magnesium levels in the blood
too much acid or carbon dioxide in the blood
If you are suffering from any of these conditions your doctor will take this into
account when deciding the correct dose of rocuronium for you.
Tell your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes.
take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor will discuss the risks and benefits of using rocuronium if you are pregnant
or breast-feeding.
Children/Elderly
DBL Rocuronium Bromide can be used in infants (28 days-23 months), children (2-11
years), adolescents (12-18 years) and elderly patients .
DBL Rocuronium Bromide used in elderly patients (65 years and older) may be at an
increased risk of residual paralysis.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with DBL Rocuronium Bromide and affect how it works.
These include:
corticosteroids, medicines used to treat severe allergies or inflammation in various
parts of your body
some antibiotics
lithium salts, a medicine used to treat and prevent mood swings (mania or depression)
in manic-depression/bipolar disorder
quinidine, calcium channel blockers, beta-blockers, medicines used to treat heart
disease or high blood pressure
diuretics (fluid tablets)
quinine, a medicine used to treat malaria
lignocaine and bupivacaine, medicines to numb the part of your body for a medical
procedure.
other muscle relaxants
carbamazepine and phenytoin, medicines used to treat epilepsy
magnesium salts, medicines used to treat constipation or in pregnant women experiencing
high blood pressure.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DBL Rocuronium Bromide.
4. How will DBL Rocuronium Bromide be given to me?
How much will be given
Your doctor will decide what dose of DBL Rocuronium Bromide you need and it will be
injected into a vein.
When DBL Rocuronium Bromide will be given
DBL Rocuronium Bromide will be given to you by a doctor, by injection into a vein.
If you use too much DBL Rocuronium Bromide
As DBL Rocuronium Bromide Injection doses are carefully worked out and are given by
a doctor experienced in its use, it is extremely unlikely that you will be given too
much.
5. What should I know while using DBL Rocuronium Bromide?
Things you should do
If you are going to have an operation it is important that you discuss you/your child’s
medical history with your doctor as it can affect how this medicine affects you.
Things you should not do
Driving or using machines
Do not drive or use any machines or tools whilst under the effects of DBL Rocuronium
Bromide .
Your doctor will tell you when it is safe to drive and operate potentially dangerous
machinery after you have been given DBL Rocuronium Bromide.
Drinking alcohol
No information available.
Looking after your medicine
DBL Rocuronium Bromide is stored in a hospital which is responsible for storing and
disposing of any unused product correctly.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Side effects
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Side effects
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What to do
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pain or irritation at injection site
flushing
red skin rash or itchy rash
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Speak to your doctor if you have any of these less serious side eff
ects and they worry you.
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Side effects
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Side effects
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What to do
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Shortness of breath, wheezing or difficulty breathing, swelling of the face, lips,
tongue or other parts of the body; feeling lightheaded or dizzy; skin rash, itching,
hives
rapid, shallow breathing, cold, clammy skin, a rapid, weak pulse, dizziness, weakness
and fainting
sudden fever with rapid heartbeat, rapid breathing and stiffness, pain and/or weakness
in your muscles
muscle weakness or paralysis
aching muscles or weakness, not caused by exercise Loss of movement
fast heartbeat
chest pain, shortness of breath, nausea, vomiting and light-headedness
dilated/enlarged pupils or fixed pupils
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If any side effects occur, they will mainly be while you are under anaesthesia and
will be managed appropriately by your anaesthetist. Otherwise, tell your doctor or
nurse straight away if you experience anything that worries you
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During and after your/your child’s surgery, your doctor will monitor you/your child’
response to DBL Rocuronium Bromide as well your recovery from anaesthesia and the
effect of muscle relaxation.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What DBL Rocuronium Bromide contains
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Active ingredient
(main ingredient)
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10 mg/mL of rocuronium bromide
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Other ingredients
(inactive ingredients)
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sodium acetate
sodium chloride
acetic acid
sodium hydroxide
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
This medicine does not contain preservatives.
It does not contain lactose, sucrose, gluten, tartrazine or any azo dyes.
What DBL Rocuronium Bromide looks like
DBL Rocuronium Bromide Injection is a clear, colourless to faintly yellow solution.
Australian Registration Number: AUST R 161275.
Who distributes DBL Rocuronium Bromide
Australian Sponsor
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in January 2024.
® Registered trademark
© Pfizer Australia Pty Ltd 2022.